Clinical Trial Specialist II
Job Description:
• Responsible for performing investigative site recruitment/feasibility, site project training, remote clinical data monitoring and resolution, site progress status tracking, in-house site management, documentation filing, and other duties in accordance with Sponsor and/or UBC requirements.
• Performs essential document collection and review for site start up and initiates in compliance with project specifications and applicable SOPs with adherence to FDA Regulations, ICH/GCP guidelines and good documentation practices.
• Demonstrates ability to successfully lead and mentor CTS staff, take on high level tasks as delegated by Project Manager/Functional Manager, and escalate and mitigate risk as appropriate.
• Manage Regulatory and Institutional Review Board (IRB) Activities: Prepare, distribute, collect, evaluate, and approve regulatory documents required for regulatory compliance and IRB submission.
• Conduct Site Management Activities: Evaluate sites to determine interest, adequate subject population, facilities, staff and qualifications to conduct a study.
• Manage site relationships to ensure positive interactions through routine site contact.
• Ensure sites meet subject safety reporting regulations: subject safety information is disseminated appropriately by evaluating consistency, quality and timeliness of serious adverse events reported by the site and submission to the IRB.
• Create and maintain Trial Master Files (TMF) and ensure Regulatory Authority and Client audit readiness of TMF.
Requirements:
• Bachelor's degree or relevant work experience required
• 2+ years of relevant clinical research experience required
• Excellent written and verbal communication skills required
• Strong Microsoft Office skills (Outlook, Word, and Excel) required
• Aptitude in learning new computer systems required
• Ability to be flexible and multitask required
• Basic medical terminology or knowledge desired.
Benefits:
• Remote opportunities
• Competitive salaries
• Growth opportunities for promotion
• 401K with company match*
• Tuition reimbursement
• Flexible work environment
• 20 days PTO
• Paid Holidays
• Employee assistance programs
• Medical, Dental, and vision coverage
• HSA/FSA
• Telemedicine (Virtual doctor appointments)
• Wellness program
• Adoption assistance
• Short term disability
• Long term disability
• Life insurance
• Discount programs
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